Kornimate/medical-research-clean huggingface dataset:
different hydration strategies associated with aerobic exercise in coronary

Conditions: Coronary Disease

Summary: the need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. however, the influence of fluid replacement when administered during and after exercise on cardiac autonomic modulation with autonomic alterations known as the coronary arteries remain poorly understood. the aim of the study was to evaluate and compare whether different hydration strategies are able to promote acceleration of the recovery of autonomic modulation in individuals with coronary artery disease undergoing aerobic exercise. this study is a cross-over clinical trial, which will be developed based on an experimental procedure performed in four stages. a total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation (cr) sessions. the participants will perform cr with mineral water intake in phase three and four. in phase three, the consumption will be done a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the second session. in phase four, hydration will be carried out in an uncontrolled manner, according to the desire to drink water during the protocol.


Eligibility criteria:
inclusion criteria: * men with coronary heart disease ischemia, over 45 years * at least three months of cardiovascular rehabilitation exclusion criteria: * smokers, alcoholics * uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases) * abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load * myocardial ischemia and / or severe ventricular arrhythmias during the exercise test

Keywords: autonomic nervous system fluid therapy heart rate exercise
digestive properties of carbohydrate-based foods

Conditions: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior

Summary: gastric emptying rate, glycemic response, fermentation, and appetitive response are being assessed after consumption of traditional west african carbohydrate-based foods (pearl millet couscous, pearl millet thick porridge) and western type carbohydrate-based foods (wheat couscous, white rice).

anecdotal evidence suggests that couscous made from pearl millet (pennisetum glaucum), hereby referred to as millet couscous, is highly satiating in populations living in the west african sahel. results from a previous human study conducted the investigators indicated that traditional west african foods made from pearl millet and sorghum (millet couscous, millet thick porridge, and sorghum thick porridge) exhibit markedly delayed rates of gastric emptying compared to western foods (pasta, boiled potatoes, and white rice) in a population from mali, africa. the delayed gastric emptying rate of the thick porridges can be attributed at least partially to the impact of viscosity, while the cause of the delayed gastric emptying rate of the millet couscous remains unclear. the overall aim of this research is to determine why millet couscous exhibits a delayed rate of gastric emptying, while also assessing other digestive properties to gain a better understanding of the factors that could be contributing to this outcome. therefore, gastric emptying rate, glycemic response, fermentation, and appetitive response are all being assessed for west african and western foods in a population residing in the united states.

Eligibility criteria:
inclusion criteria: * normal body mass index (18.5 \< bmi \< 25 kg/m2) * normal fasting blood glucose exclusion criteria: * diabetes * allergy to millet * allergy or sensitivity/intolerance to gluten * history of gastrointestinal disease * pregnant or nursing
intraocular pressure control after anterior segment laser - comparison between 2 drugs

Conditions: Glaucoma, Narrow Angle

Summary: the purpose of this study is to compare the intra-ocular (iop) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (lpi).

postoperative iop elevation is one of the most common complications after lpi.previous studies showed that brimonidine 0.2% is effective in blunting iop spikes after lpi.this prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in \>180o on gonioscopy.pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. lpi with nd:yag laser is performed 30 minutes later in both eyes by a single glaucoma specialist. iop measurements are assessed before the use of any eyedrop (basal iop), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after lpi. pachymetry, ultrasonic biometry, gonioscopy, and total yag laser energy are recorded. non-parametric test will be used for analysis.

Eligibility criteria:
inclusion criteria: * bilateral narrow angles, defined by irido-trabecular contact in \>180o on gonioscopy exclusion criteria: * previous cataract surgery

Keywords: intra-ocular pressure iridectomy gonioscopy ocular tonometry
modified autoset device vs existing autoset device, the assessment of efficacy and subjective comfort of the treatment.

Conditions: Sleep Apnea

Summary: the purpose of this study is to determine if the performance of the modified autoset device is equivalent or better than the existing autoset device (vpap auto) in the efficacy of the treatment and the subjective comfort.

obstructive sleep apnea (osa) is characterised by a partial or complete collapse of the upper airway during sleep. the treatment of choice for osa is continuous positive airway pressure (cpap). cpap acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. the modified device to be assessed in this study will act in a similar way to the existing device, vpap auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 years * patients who are on cpap therapy in autoset mode for no less than 6 months * patients who are using resmed masks exclusion criteria: * patients who are unable to provide written informed consent * patients who are unable to comprehend written and spoken english * patients who are using bilevel pap * patients who are pregnant * patients who are suffering any of the following: * acute respiratory infection * acute sinusitis, otitis media or perforated eardrum * pneumothorax or pneumomediastinum * recent history of severe epistaxis requiring medical attention
modeling the effects of chronic marijuana use on neuroinflammation and hiv-related neuronal injury

Conditions: Cannabis; HIV; Inflammation; Cognition; Neuroimaging

Summary: this study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on hiv-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with hiv.


Eligibility criteria:
inclusion criteria: * verified hiv status * current marijuana use (mj+ groups only) * no current marijuana use (mj- groups only) * current engagement in hiv care (hiv+ participants only) * receipt of cart as first-line of treatment (hiv+ participants only) * stable cart regimen (hiv+ participants only) * undetectable hiv rna viral load for \>1 year (hiv+ participants only) exclusion criteria: * lifetime abuse for any illicit drug other than marijuana * \<9th grade education; illiteracy or lack of fluency in english * history of moderate or severe head trauma * unstable or serious neurological disorders * severe mental illness * systemic autoimmune diseases * immunotherapy * mri contraindications
validation of completion of items 18, 19 and 22 of the motor function measure (mfm) on a digital tablet

Conditions: Neuromuscular Diseases

Summary: motor function measure (mfm) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. despite standardized motor function measure (mfm) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist. among the 32 items of the mfm, 3 currently require the use of a paper, and could be automated by using a digital tablet. it is the item 18 where the patient traces the edge of a compact disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. the reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. the second interest is to implement directly the mfm data in the mfm base. the hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease.


Eligibility criteria:
inclusion criteria: * patients with a labelled neuromuscular disease * patients with motor function measure in one of the participating services during their usual follow-up * patients who received the information and did not object to participating in the study or their parents for the children exclusion criteria: * patients passing their motor function measure as part of another research protocol
effects of supplement containing various probiotics and fermentation products on obesity

Conditions: Obesity

Summary: the purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.


Eligibility criteria:
inclusion criteria: * healthy as based on medical history and physical examination * bmi between 25 and 30 kg/m2 * willing not to serve as blood donor during the study * informed consent signed exclusion criteria: * food allergy * female subjects who are pregnant or nursing a child * participation in any clinical trial up to 90 days before day 01 of this study * renal or hepatic dysfunction * heart disease * under medication * subjects who are taking functional food designed for weight loss or serum lipid reduction
cccr lupus patient navigator program

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: to address the health disparities in sle outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. the navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. the most effective patient navigators address both health system and patient barriers.


Eligibility criteria:
inclusion criteria: 1. self-identified minority. 2. patients ≥ 18 years of age as documented in the electronic medical record. 3. meeting either american college of rheumatology or slicc classification criteria for sle as documented in the electronic medical record. 4. ability to speak and understand english by self-report. 5. in the past six months having ≥ 1 missed clinic or diagnostic study/laboratory visit as documented in the electronic medical record, or self-reported failure to adhere with prescribed medical therapy for sle. 6. in the past six months having been prescribed at least one immunosuppressive medication for sle activity as documented in the electronic medical record regardless of whether taking the medication. 7. currently enrolled into the core center for clinical research (cccr; pro 00021985) with properly executed informed consent document and hipaa authorization. 8. have telephone access. exclusion criteria: 1. unwilling or unable to give informed consent. 2. being a prisoner or institutionalized individual. 3. without telephone access. 4. do not meet all of the inclusion criteria listed above.
the infinite study: a prospective investigation of a nutrient-dense diet in early addiction recovery

Conditions: Mental Health Issue; Addiction

Summary: the trial will be placed within an ongoing addiction recovery program at infinite recovery in austin, tx. members with any addiction enrolling in an inpatient treatment program at infinite recovery will be recruited into this 1-year study to evaluate the effectiveness of a plant-based diet to aid drug and/or alcohol addiction recovery. volunteers willing to participate in the trial will be randomly assigned to a treatment or control group. those in the treatment group will follow the standard protocol offered by infinite recovery, with the exception that they will be provided with only plant-based meals. both groups will also receive nutrition education to support their dietary plan. several health and wellbeing endpoints will be assessed as part of the standard care at infinite recovery, combined with a few additional measurements described within this study protocol.


Eligibility criteria:
inclusion criteria: * age 18 or older * entering inpatient treatment at infinite recovery addiction treatment facility exclusion criteria: * pregnant * psychiatrically unstable.
a health and wellness lifestyle program to support community-dwelling persons with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.

the purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (powers-tbi) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with tbi and their caregivers. the treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. the goals are to evaluate the impact of the treatment program on improving health outcomes for people with tbi. the investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.

Eligibility criteria:
inclusion criteria: * age 19 years or older * sustained a tbi * at least 6-months or greater out from injury * willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use) * able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor) * not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention * indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition * has access to a telephone * has regular access to the internet from a computer or laptop * not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss) * does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded) exclusion criteria: * non-english speaking * difficulty hearing * significant problems with communication
bosentan in digital ulcers

Conditions: Digital Ulcers

Summary: the aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in systemic sclerosis (ssc) patients suffering from ischemic digital ulcers (dus).


Eligibility criteria:
inclusion criteria: 1. patients with ssc according to the classification criteria of the american college of rheumatology 2. ssc patients with at least one du at baseline qualifying as a cu (see definition section 3.2.2) 3. cu occurred \ 1 week prior to randomization. the subset of patients with ssc felt to be at high risk for dus will be identified in the screening period but will not be eligible for enrollment until a cu has developed 4. male or female patients \>/= 18 years of age 5. women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination 6. women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile 7. signed informed consent. exclusion criteria: 1. dus due to condition other than ssc 2. severe pah (who class iii and iv) 3. systolic blood pressure \< 85 mmhg 4. hemoglobin concentration \< 75% of the lower limit of the normal range 5. ast and/or alt values greater than 3 times the upper limit of normal 6. moderate to severe hepatic impairment, i.e., child-pugh class b or c 7. severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition 8. pregnancy or breast-feeding 9. previous treatment with bosentan 10. treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine a, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization 11. local injection of botulinum toxin in an affected finger 1 month prior to randomization 12. treatment with parenteral prostanoids (prostaglandin e, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization 13. treatment with inhaled or oral prostanoids one month prior to randomization 14. systemic antibiotics to treat infection of dus 2 weeks prior to randomization 15. treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction 16. body weight \< 40 kg 17. patient with conditions that prevent compliance with the protocol or adhering to therapy 18. patient who received an investigational product within 1 month preceding screening 19. known hypersensitivity to bosentan or any of the excipients.

Keywords: digital ulcers systemic sclerosis finger ulcers bosentan open label
diphtheria, tetanus, poliomyelitis -pertussis-hib immunisation in preterm-born neonates

Conditions: Hib Immunisation in Very Preterm-born Infants; Pertussis Immunisation in Very Preterm-born Infants

Summary: preterm neonates are fragile to infections. their immune system is immature, yet in france, primary vaccines are injected at two months of age, as in term infants. recommendations for vaccinations in infants have changed in france in 2013, suppressing the second injection at three months after birth. preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered. the investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.


Eligibility criteria:
inclusion criteria: * infants born \< 33 weeks gestation in nancy and thionville maternity wards * signed parental consent exclusion criteria: * immunodeficiency * vaccine contra-indication

Keywords: vaccination very preterm-born infants hib immunisation pertussis immunisation
comparison of the impact of diet vs thiazide in bmd in children with idiopathic hypercalciuria

Conditions: Hypercalciuria; Idiopathic; Nephrolithiasis

Summary: the investigator's objective is to compare and evaluate the impact of nutritional treatment vs. pharmacological treatment (hydrochlorothiazide) in bone mineral density in children with idiopathic hypercalciuria. a randomized, open-label, one-year follow-up study will be conducted in children aged 5 to 21 years with a confirmed diagnosis of idiopathic hypercalciuria or lithiasis, excluding those patients with secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin d, bartter syndrome, primary hyperparathyroidism), previous kidney transplantation. the impact of diet (hyposodic, calcium intake according to dir for age, normal protein intake and high water intake) will be evaluated vs. the pharmacological treatment (hydrochlorothiazide) on bone mineral density.

a randomized, open-label clinical trial will be conducted with a one-year follow-up. for which basal measurement of calciuria, citraturia, serum creatinine, serum and urinary electrolytes, parathyroid hormone, vitamin d levels and renal ultrasound, as well as dietary intake (protein, energy, salt and water). the dietary intake per day of food and pharmacological treatment will be evaluated quarterly, body composition (anthropometry) and serum and urinary electrolyte levels will be measured; bone constitution (dxa, quantitative bone ultrasound), il-1 (as inflammatory markers) and vitamin d will be evaluated every six months. participants will be blinded to the pharmacological treatment they will receive. the randomization of the participants will be done through the page www.randomization.com. the randomization was performed by blocks, where blocks of 6 members each were made i. group 1: only recommendations of water intake and reduction of salt intake and hydrochlorothiazide will be given (the dose will be assigned according to weight and sex by a pediatric nephrologist, dose of 0.5-1.5mg / kg / day, starting with the dose 1 mg / kg). hydrochlorothiazide will be provided to the patient. ii. group 2: placebo capsules and a strict diet plan will be given. the placebo will look similar to that of hydrochlorothiazide and will be prepared in the nephrology research laboratory by biol. ana maría hernández sánchez and quim lourdes ortiz. the feeding plan will be appropriate for the patient, it will consist of: 1. 40 ml / kg / day of water 2. protein according to age and sex 3. recommendations for low sodium intake 4. calcium according to age and sex (minimum 800mg)

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic hypercalciuria * man or women * 5 to 21 years exclusion criteria: * clinical diagnosis of secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin d, bartter syndrome, primary hyperparathyroidism) * previous kidney transplant * clinical diagnosis of kidney disease. * vitamin d intake (more than 800 mg/day)

Keywords: diet drinking water salt dietaryprotein